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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MARTECH / MDI SOF-CURL URETERAL STENT, 4.5FR X 24CM
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MARTECH / MDI SOF-CURL URETERAL STENT, 4.5FR X 24CM Back to Search Results
Model Number SSC4524
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/26/2016
Event Type  malfunction  
Manufacturer Narrative
The device has been discarded by the facility.As a result, a determination cannot be made at this time.If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.Devise was discarded.
 
Event Description
When doing cystoscopy at start of pcnl they realized the stent was no longer curled in the bladder and it had moved up in to ureter so had to be retrieved with grasping forceps.
 
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Brand Name
SOF-CURL URETERAL STENT, 4.5FR X 24CM
Type of Device
URETERAL STENT
Manufacturer (Section D)
MARTECH / MDI
1500 delp drive
harleysville PA 19438
Manufacturer Contact
terrence sullivan
136 turnpike road
southborough, MA 01772
508804-273
MDR Report Key5997578
MDR Text Key57054152
Report Number3011050570-2016-00010
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PK930733
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 10/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSSC4524
Device Lot NumberMGSB090
Other Device ID NumberUDI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/26/2016
Initial Date FDA Received10/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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